- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07633340
Routine Rehabilitation Versus Shock Wave Therapy for Scapular Dyskinesis
Routine Rehabilitation Versus Shock Wave Therapy for Patients With Scapular Dyskinesis
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Aliaa Mamdouh Abdelaziz Farag, MD
- Telefonnummer: 01069468486
- E-post: aliaa.mamdouh@med.tanta.edu.eg
Studiesteder
-
-
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Tanta, Egypt
- Rekruttering
- Tanta University
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- This study included 100 patients with scapular dyskinesis. The patients were divided into 2 groups: one group was treated with ESWT and routine rehabilitation, and the second group was treated with routine rehabilitation only. Adult patients with scapular dyskinesia who exhibited signs of dyskinesia for at least 6 months before enrolment in the study will be selected.
Exclusion Criteria:
- History of shoulder or thorax trauma or surgery.
- The back pain involved the cervical spine and thoracic spine.
- Participants with neurologic deficits
- history of inflammatory conditions such as ankylosing spondylitis
4- Certain situations where shockwave therapy is not recommended. These include:
Absolute contraindications:
- Active infection (i.e., osteomyelitis)
- Malignant tumors, particularly at the treatment site (focused shockwave)
- Pregnancy
Relative Contraindications:
- The brain or nerve in the treatment focus
- Treatment focused on the lungs or pleura
- Significant coagulopathy (increased risk of bleeding, such as haemophilia)
- Epiphyseal plate in treatment focus
Important considerations:
- Cardiac pacemakers or other implantable devices
- Current nonsteroidal anti-inflammatory drug use
- Current anticoagulation use
- Recent corticosteroid injections (receiving a steroid injection into the area to be treated within the previous 12 weeks).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Radial extracorporeal shock wave therapy/ Intervention group
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (DornierMedTech GmbH, Wessling, Germany) under ultrasound guidance, at periscapular muscles .
1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.
The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month for the treatment group and without operating the machine for the sham group .
No anesthetic oranalgesic drugs will be administered to patients during the therapy session.
Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist.
|
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (DornierMedTech GmbH, Wessling, Germany) under ultrasound guidance, at periscapular muscles .
1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.
The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month for the treatment group and without operating the machine for the sham group .
No anesthetic oranalgesic drugs will be administered to patients during the therapy session.
Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist.
|
|
Sham-komparator: Sham rESWT/ Control group
Sham rESWT once weekly for one month.
The Dornier AR2 machine (Dornier MedTechGmbH, Wessling, Germany) used under ultrasound guidance, at affested periscapular muscles .
1.500 pulses will be applied by anR20 probe with intensity of 0.10 mJ to0.3mJ/mm2 (2.5 bar) & frequency 4 Hz every week for one month without operating the machine.
|
The Dornier AR2 machine (Dornier MedTechGmbH, Wessling, Germany) used under ultrasound guidance, at affested periscapular muscles .
1.500 pulses will be applied by anR20 probe with intensity of 0.10 mJ to0.3mJ/mm2 (2.5 bar) & frequency 4 Hz every week for one month without operating the machine.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test
Tidsramme: 1 month after intervention
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1 month after intervention
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 36264PR768/7/24
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Results will be published by the investigators in academic journal.
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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